Opening up data at the European Medicines Agency
BMJPublished 10 May 2011
Peter C Gøtzsche, Andreas Jørgensen
Citations105
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TL;DR
Peter Gøtzsche and Anders Jørgensen describe their efforts to get access to unpublished trial reports from the European Medicines Agency.
Abstract
Widespread selective reporting of research results means we don't know the true benefits and harms of prescribed drugs. Peter Gøtzsche and Anders Jørgensen describe their efforts to get access to unpublished trial reports from the European Medicines Agency
Keywords
MedicinePharmacology, Toxicology and Pharmaceutics
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